Effects of Smoking Environments on Brain Reactivity

NCT ID: NCT03421210

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2019-12-23

Brief Summary

The goal of this study is to evaluate correlations between brain reactivity (as assessed via functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of smoking in a specific location. The investigators will use ecological momentary assessment (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after quitting smoking. The investigators propose to identify 48 regular cigarette smokers who will complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI session and 4 post-quit medication check sessions). Multiple methods will be used to test hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine correlation between brain responses to smoking environments (minus non-smoking environments) and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global Positioning System (GPS) analysis will primarily focus on locations where smokers smoke before and after quitting smoking. The investigators will evaluate whether EMA-assessed smoking intensity values are correlated with brain responses to these personal smoking environments.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Nicotine Replacement Therapy

Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.

Group Type: OTHER

Nicotine patch

Intervention Type: DRUG

Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.

Interventions

Nicotine patch

Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. generally healthy [(i.e. ambulatory, not currently sick)]

2. between the ages of 18 and 65

3. smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year

4. an expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).

5. interest in quitting smoking within the timeframe of the experiment.

6. ability to identify 4 personal smoking and 4 personal non-smoking places.

7. right handed as measured by a three-item scale used in our laboratory

8. own a smartphone

Exclusion Criteria

1. immediate or no desire to quit smoking;

2. inability to attend all required experimental sessions;

3. use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;

4. current alcohol or drug abuse;

5. positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)

1. marijuana will be tested for but will not be exclusionary;

2. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;

3. participants failing the toxicology screen will be allowed to re-screen once;

6. current use of nicotine replacement therapy or other smoking cessation treatment;

7. screening systolic BP greater than 140 (participants failing for blood pressure will be allowed to rescreen once)

8. screening diastolic BP greater than 90 (participants failing for blood pressure will be allowed to rescreen once)

9. screening heart rate greater than 100 (participants failing for heart rate will be allowed to rescreen once)

10. presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)

11. report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems, heart disease, heart attack in the past 90 days, irregular heartbeat)

12. medical condition that may contraindicate participation in the opinion of the investigator and study physician.

13. current major psychiatric disease such as schizophrenia or schizoaffective disorder

14. currently pregnant, breast feeding or likely to become pregnant;

15. a quit attempt resulting in greater than 3 days of abstinence in the past 30 days

16. presence of conditions that would make MRI unsafe (e.g., pacemaker)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis J McClernon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01DA038442

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00089183

Identifier Type: -

Identifier Source: org_study_id